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Medtech: BrainTale gathers €4.5 million to accelerate the development of its solution for diagnosis, monitoring and prediction of neurological disorders

Strasbourg, June 20, 2023

BrainTale, a French medtech deciphering white matter to enable better brain care, announces it has gathered € 4.5 million from Capital Grand Est and MACSF, as well as business angels, to accelerate its development in Europe and the United States. With this fundraising, BrainTale aims to provide physicians and pharmaceutical companies with innovative solutions to improve the diagnosis, monitoring and prediction of neurological diseases and disorders, in particular Alzheimer's and Parkinson’s disease, amyotrophic lateral sclerosis and traumatic brain injury.

Founded in 2018 and supported from the outset by LallianSe, the life sciences integrator, BrainTale has developed and commercializes an accessible, reliable and clinically validated brain measurement digital platform solution for drug developers and physicians - neurologists, neuroradiologists and intensivists. Today, the company has gathered €4.5 million from Capital Grand Est, MACSF, business angels and healthcare professionals, supplemented by a Deeptech plan from Bpifrance Grand Est. With its first customers in Europe including hospitals (Paris Region Greater Hospitals, Hôpitaux Universitaires de Strasbourg) and biotech (Minoryx), as well as partners in the United States (Massachusetts General Hospital - Harvard), BrainTale aims an accelerating its expansion on both sides of the Atlantic.

White matter, a "new frontier" to explore

Long underestimated in neuroscience, white matter, which represents 60% of the human brain, plays a key role in its proper functioning, development, and aging, whether normal or pathological. The vast majority of brain diseases - such as Alzheimer's, Parkinson's, amyotrophic lateral sclerosis, adrenoleukodystrophy or the consequences of coma - are linked to primary or secondary alterations in white matter. Of note, a prediction score of recovery in comatose patients derived from white matter measurements enables physicians to significantly improve the daily care of these patients. A medical frontier that had never been explored before.

To explore this new continent of the brain, BrainTale is developing a measurement solution that improves diagnosis, monitoring and prediction with a non-invasive, pain-free, efficient and clinically validated approach. Co-founded by Professors Louis Puybasset (Intensivist, Paris Region Greater Hospitals, Paris), Damien Galanaud (Neuroradiologist, Paris Region Greater Hospitals, Paris), Lionel Velly (Intensivist, Hôpital de la Timone, Marseille Hospitals, Marseille), Didier Cassereau (Research Professor, ESPCI), Vincent Perlbarg (Engineer and PhD in Medical Physics), and LallianSe, the life sciences integrator BrainTale today employs a dozen people who develop these innovative, patented and proprietary solutions, based on international prospective, multicentric clinical development by teams of physicians, notably from the Paris Region Greater Hospitals.

A biomarker platform to measure the brain

BrainTale-care is a software medical device available in SaaS (Software as a Service) mode to any physician or drug development player based on diffusion MRI (magnetic resonance imaging). The modular platform enables the identification of white matter alterations and can provide individualized prediction scores.

The platform aims to actively contribute to the development of new drugs by drug development companies: BrainTale's proprietary biomarkers are developed to correlate with traditional clinical scores and can make a significant distinction between active and placebo arms, improving clinical trials and supporting treatment efficacy demonstration. The potential of BrainTale biomarkers has already been demonstrated in some demyelinating diseases such as adrenoleukodystrophy (ALD).

The availability of BrainTale's solution also enables real life understanding and observation supporting market access and paving the way for the companion biomarker principle in neurosciences.

"After 15 years of academic research and 5 years of investment, the solutions developed by BrainTale are finally available to patients and my colleagues. Responding to the unmet medical need that has been the driving force behind this ambitious project since its inception is one of the major challenges of the coming years, and BrainTale's development is perfectly in line with this dynamic", comments Prof. Louis Puybasset, chairman of the scientific advisory board and co-founder of BrainTale.

"LallianSe's unfailing support and the confidence shown in us by our investors now enable us to move up a gear. Our team will be able to accelerate our innovative developments to make BrainTale biomarkers a reference for the benefit of patients suffering from neurological disorders", adds Vincent Perlbarg, president, scientific director and co-founder of BrainTale.

"This fundraising is a decisive step for BrainTale, and enables us to look forward with ambition to our next development milestones. The commitment of Capital Grand Est and MACSF by our side reinforces our strategy to establish BrainTale's brain measurement as a reference, in particular to enable drug developers to accelerate the development of new therapies in a more agile and efficient way, bringing a new dynamic in neurosciences", explains Julie Rachline, president of LallianSe, and CEO of BrainTale.

"We are delighted to be able to support BrainTale in this acceleration phase alongside MACSF and an experienced and talented management team. BrainTale offers a disruptive product that combines digital health with cutting-edge fundamental research, key ingredients for success", affirms Virginie Miath, investment director at Capital Grand Est.

"We are proud to include BrainTale in our portfolio of e-health start-ups. This investment is perfectly in line with MACSF's strategy of helping to improve the world of healthcare. BrainTale improves the practice of healthcare professionals and the quality of care by improving the prediction of neurological diseases such as Alzheimer's and Parkinson's diseases. This round of financing will enable BrainTale to enter a new phase in its development," states Sébastien Couvet, head of the MACSF Group's e-health portfolio.

BRAINTALE PRESS CONTACTS

Laure Schlagdenhauffen laure.schlagdenhauffen@gmail.com +33 6 30 11 97 50

Anna Casal casal.anna@gmail.com +33 6 50 61 55 71

About BrainTale 

BrainTale is an innovative medtech company deciphering white matter to enable better brain care with clinically validated prognostic solutions. With non-invasive, sensitive and reliable measurements of white matter microstructure alterations, BrainTale offers a digital biomarkers platform to support clinical decision-making. BrainTale enables the identification of patients at risk, early diagnosis and monitoring of disease progression and the effectiveness of treatments in neurology, in particular for demyelinating diseases, amyotrophic lateral sclerosis and neurodegenerative diseases. Based on more than 15 years of research and development, BrainTale's products are developed to meet the medical needs and expectations of healthcare professionals for the benefit of patients. 

Since its inception in 2018, the company has implemented a comprehensive quality management system and is now ISO 13485:2016 certified, with a suite of products available on the European market under the European Medical Device Regulation (MDR). 

For more information, please visit www.braintale.eu  

About LallianSe

Pioneer and initiator of the life sciences integrator concept, LallianSe transforms innovations into economic successes through the co-construction and execution of compelling investment theses. Immersed in care, LallianSe contributes to better health through its hospital-based coworking spaces, dedicated events, Experts and Entrepreneurs in Residence, specifically mobilized for each company and its education journeys. Braintale is LallianSe's flagship contribution.

Contact – www.lallianse.com

About Capital Grand Est

Capital Grand Est is an independent regional private equity company approved by the AMF.

Since 2012, Capital Grand Est's 13-strong team has supported more than 60 companies in the Grand Est and Bourgogne Franche Comté regions. With close to €200 million in assets under management, spread across 5 investment vehicles, Capital Grand Est structures capital operations with different types of companies in the region, to accelerate their success. It offers young, innovative start-ups capital support at the seed stage. For more mature companies, we structure development capital operations to accelerate their growth, or transfer capital operations to support their capital evolution.

Visit: www.capitalgrandest.eu  

Follow us on LinkedIn: https://www.linkedin.com/company/capitalgrandest

About MACSF group

As the leading insurer of healthcare professionals, MACSF (Mutuelle d'assurance du corps de santé français) has been serving all healthcare professionals in France for over a century. It employs 1,600 people and generates sales of around 2 billion euros. True to its vocation as a professional mutual insurance company, MACSF insures the private and professional risks of over a million members and customers.

To find out more: macsf.fr

Press contacts: 

Séverine Sollier - 06 14 84 52 34 – severine.sollier@macsf.fr

Annie Cohen - 06 71 01 63 06 - annie.cohen@macsf.fr

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BrainTale has been invited at the AD/PD conference to present the interest of its digital biomarkers platform to improve the management of Alzheimer's disease

Strasbourg, April 6th, 2023

BrainTale, a medtech deciphering white matter to enable better brain care, spin-off of the Paris Region Greater Hospitals, was invited to present with an oral communication at the AD/PD conference (International Conference on Alzheimer's and Parkinson's Disease and related neurological disorders) - held in Gothenburg (Sweden) from March 28 to April 1, 2023 the interest of its biomarkers platform in Alzheimer’s disease patients. Vincent Perlbarg, co-founder, scientific director and president of BrainTale, presented data obtained in the early diagnosis of Alzheimer's disease supporting the interest of brainTale-care digital biomarker platform in patient management as well as in the development of new therapeutic approaches.

Long underestimated in neuroscience, white matter, which represents 80% of the human brain, plays a key role in its proper functioning, development, and aging, whether normal or pathological. Thus, BrainTale has been developing non-invasive, accessible, effective and clinically validated measurement and prediction tools for patients suffering from brain diseases since its creation in 2018.

Affecting more than 10 million people worldwide every year, Alzheimer's disease incidence tends to increase. The disease is often diagnosed too late to effectively slow its progression, although white matter lesions can be detected at an early stage, notably on the myelin sheath, axons and oligodendrocyte cells.

The oral presentation entitled "Evaluation of digital biomarkers from diffusion MRI to monitor Alzheimer's disease in the daily clinic" highlighted the study conducted on 113 subjects (66 healthy subjects, 34 patients with mild cognitive impairment, 13 patients with dementia) from 5 different institutions. This multicentre analysis showed a stratification of patients based on white matter assessments that were statistically different (p<0.05) for the three categories of subjects: decreased anisotropy fraction (AF) and increased mean diffusivity (MD).

These preliminary data highlight the sensitivity of the white matter biomarkers developed by BrainTale to specific Alzheimer's disease, notably in early forms of the disease. It paves the way for the relevance of such biomarkers as complementary to biological markers not only for early diagnosis but also, and possibly more importantly, for disease progression monitoring. With the new version of the brainTale-care biomarker platform available since a few weeks, centers and partners equipped with BrainTale technology can now improve the management of these patients.

"The invitation for a presentation during AD/PD conference is a strong signal about the interest of our solutions to improve the management of patients in real life and to accompany the development of new therapies against these neurodegenerative diseases" comments Vincent Perlbarg "Our work allows a non-invasive, reproducible, sensitive and reliable approach of white matter alterations to better diagnose and treat Alzheimer's disease patients in the daily clinic; the whole team is very committed to improve the management of patients" he adds.

About BrainTale  

BrainTale is an innovative medtech company deciphering white matter to enable better brain care with clinically validated prognostic solutions. With non-invasive, sensitive and reliable measurements of white matter microstructure alterations, BrainTale offers a digital biomarkers platform to support clinical decision-making. BrainTale enables the identification of patients at risk, early diagnosis and monitoring of disease progression and the effectiveness of treatments in neurology, in particular for demyelinating diseases, amyotrophic lateral sclerosis and neurodegenerative diseases. Based on more than 15 years of research and development, BrainTale's products are developed to meet the medical needs and expectations of healthcare professionals for the benefit of patients.

Since its inception in 2018, the company has implemented a comprehensive quality management system and is now ISO 13485:2016 certified, with a suite of products available on the European market under the European Medical Device Regulation (MDR).

For more information, please visit www.braintale.eu

by braintale

BrainTale unveils the new version of its digital biomarkers platform brainTale-care CE-marked under the MDR 2017/745

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BrainTale has presented the interest if its digital biomarkers platform in differential diagnosis during the 15th edition of Clinical Trials on Alzheimer’s Disease conference

BrainTale, a medtech deciphering white matter to enable better brain care, spin off from the Paris Region Greater Hospitals, has presented the "Evaluation of a clinically validated digital platform to provide Diffusion MRI biomarkers in Alzheimer's disease" during the 15th edition of the Clinical Trials on Alzheimer's Disease conference (CTAD 2022) held in San Francisco and online from November 29 to December 2, 2022. 

The Clinical Trials on Alzheimer's Disease conference is a meeting focused entirely on Alzheimer’s Disease Therapeutic Trials with key leaders in Alzheimer Disease research from Industry and Academia getting together and forming partnerships with the objective of speeding the development of effective treatments to fight the disease. 

Long underestimated in neuroscience, white matter, which represents 80% of the human brain, plays a key role in its proper functioning, development, and aging, whether normal or pathological. As a result, since its inception in 2018, BrainTale has been developing non-invasive, accessible, effective, and clinically validated measurement and prediction solutions for physicians treating patients with brain diseases.  

Alzheimer’s disease affects about 10 million people per year worldwide and its incidence rate tends to increase year after year. The disease is often diagnosed too late to effectively slow its progression, although lesions are visible at an early stage, notably on the myelin sheath, axons, and oligodendrocyte cells.  

Data of 113 subjects (66 healthy patients, 34 patients with mild cognitive impairment, 13 patients with dementia) from 5 centers were processed on the BrainTale platform. The multicentric study showed that the analysis resulting from the platform processing has demonstrated statistically different white matter assessments for the 3 subjects’ categories. Results show that BrainTale biomarkers are relevant biomarkers of disease severity, and that the platform has the potential for a differentiated diagnosis perspective.  

BrainTale digital biomarkers platform offers the potential to diagnose Alzheimer's patients at an early stage and monitor disease evolution, as well as drug efficacy as already demonstrated in other neurodegenerative conditions. This potential of impact for Alzheimer’s patients, community and stakeholders has already been awarded the Robert D. Zimmerman Scientific Award 2022 by the Eastern NeuroRadiology Society. 

Vincent Perlbarg, cofounder, CSO and president comments: "This preliminary work shows the importance of integrating white matter biomarkers for neurodegenerative diseases. Our data suggest a very exciting complementary approach to existing initiatives to better diagnose, and ultimately better treat Alzheimer’s disease patients”.  “Our approach enables non-invasive, sensitive and reliable assessments of white matter alterations that are both available in the clinic and implemented in clinical trials to improve success rates and support efficient clinical developments.”  he adds.   

About BrainTale  

BrainTale is an innovative medtech company deciphering white matter to enable better brain care with clinically validated prognostic solutions. With non-invasive, sensitive and reliable measurements of white matter microstructure alterations, Braintale offers a digital biomarkers platform to support clinical decision-making. Braintale enables the identification of patients at risk, early diagnosis and monitoring of disease progression and the effectiveness of treatments in neurology, in particular for demyelinating diseases, amyotrophic lateral sclerosis and neurodegenerative diseas es. Based on more than 15 years of research and development, Braintale's products are developed to meet the medical needs and expectations of healthcare professionals for the benefit of patients. 

Since its inception in 2018, the company has implemented a comprehensive quality management system and is now ISO 13485:2016 certified, with a suite of products available on the European market under the European Medical Device Regulation (MDR). 

For more information, please visit www.braintale.eu  

Contacts 

Braintale - Julie Rachline, CEO julie.rachline@braintale.eu +33 6 62 42 03 58 

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American Academy of Neurology (AAN 2022) – Braintale showcases together with Minoryx data from its biomarker platform for disease and treatment monitoring of X-linked Adrenoleukodystrophy and strengthens collaboration

Strasbourg, April 25th 2022

BrainTale, a medtech that is deciphering white matter, spin off from the Assistance Publique-Hôpitaux de Paris, showcases, with Minoryx, a biotechnology company developing a treatment for X-linked Adrenoleukodystrophy (X-ALD), the results of the multicentric ADVANCE sub study with Braintale biomarker platform on the occasion of the American Academy of Neurology (AAN). The data were presented digitally on April 24th, 2022. This has also been the occasion to deepen the collaboration between the two companies.

Long underestimated in neurosciences, white matter, which represents 80% of the human brain, plays a key role in its proper functioning, development, and aging, whether normal or pathological. Accordingly, Braintale has been developing, since its inception in 2018, non-invasive, accessible, effective and clinically validated measurement and prediction tools for physicians treating patients suffering from brain diseases.

The BrainTale platform includes AI-processed CE-marked digital solutions, deployed across three modules. BrainQuant enables white matter quantification, brainScore powers clinical prediction and MyelinDex, monitors myelin integrity. Beyond demyelinating conditions, the platform has also been successfully implemented to monitor patients with amyotrophic lateral sclerosis (ALS) and predict recovery for comatose patients after cardiac arrest or trauma brain injury.

X-ALD is an inherited orphan neurodegenerative disease. The most common form is adrenomyeloneuropathy (AMN), which is a highly debilitating chronic disease affecting male and female X-ALD patients reaching adulthood. There is currently no approved treatment for AMN patients. X-ALD male patients can also develop the acute cerebral form, cALD, in both pediatric age and adulthood. cALD results in aggressive brain inflammation leading to permanent disability and death within 2-4 years.

Leriglitazone, a novel brain penetrant PPAR gamma agonist, recently showed significant clinical benefit in Minoryx’s ADVANCE Phase II/III clinical trial in adult male patients with AMN. A separate phase II/III study in male pediatric patients with early stage cALD is ongoing (NEXUS).

On the occasion of the American Academy of Neurology, Braintale and Minoryx jointly presented additional results of a multicenter sub-study from the ADVANCE trial. The abstract is available online: https://index.mirasmart.com/aan2022/PDFfiles/AAN2022-002872.html
Beyond the characterization of MyelinDex as a relevant biomarker for monitoring disease progression and therapeutic efficacy, these data further support the efficacy of leriglitazone and its potential to improve myelin integrity in the brain of patients affected by AMN. These results pave the way to use of MyelinDex for disease and treatment monitoring in clinical trials as well as patient management in a hospital setting.

The collaboration between the two companies has expanded in order, notably, to implement the use of MyelinDex in additional clinical trials to further characterize beneficial impact of leriglitazone on myelin content, while contributing to a better understanding of X-ALD.

“We are very excited to see the potential of Braintale’s technology to deliver precise and longitudinal analysis of white matter” said Marc Martinell, CEO of Minoryx Therapeutics. “These results are aligned with preclinical data showing the impact of leriglitazone on myelination”.

“Pleased with the success of our collaboration to date, Minoryx and Braintale teams have decided to extend their partnership exploring the use of biomarkers developed with the Braintale platforms. Now, together, we are contributing to better understand and improve follow-up, treatment, and stratification of patients with this devastating orphan disease”, explains Julie Rachline, co-founder and CEO of Braintale through LallianSe.

About BrainTale
BrainTale is an innovative medtech company deciphering white matter to enable better care in neurology and intensive care with clinically validated prognostic solutions. With noninvasive, sensitive and reliable measurements of white matter microstructure alterations, Braintale offers a digital biomarkers platform to support clinical decision-making. Braintale enables the identification of patients at risk, early diagnosis and monitoring of disease progression and the effectiveness of treatments in neurology, in particular for demyelinating diseases, amyotrophic lateral sclerosis and neurodegenerative diseases. Based on more than 15 years of research and development, Braintale's products are developed to meet the medical needs and expectations of healthcare professionals for the benefit of patients. Since its inception in 2018, the company has implemented a comprehensive quality management system and is now ISO 13485:2016 certified, with a suite of products available on the European market under the European Medical Device Regulation (MDR).

For more information, please visit www.braintale.eu

Contacts
Braintale - Julie Rachline, CEO julie.rachline@braintale.eu +33 6 62 42 03 58

BRAINTALE, whose head office is 11 rue de l'Académie 67000 - STRASBOURG, is registered in the Trade and Companies Register under number 840 995 138 RCS STRASBOURG

Last update : 09/19/2022

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